Cluster HeadacheDETECTNCT05857098
Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients
An observational study of Cluster Headache and Trigeminal Autonomic Cephalgia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (CH) is still partially unknown. Three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cluster Headache, Trigeminal Autonomic Cephalgia
- What is being tested?
- Local Field potential recording
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients suffering from refractry chronic cluster headache
Who may be able to join
- Adult patients (age : 18-70 years-old) suffering from refractory chronic cluster headache
- Patients eligible for a deep brain stimulation in the ventral tegmental area of the mesencephalon
- Patients implanted with a deep brain stimulation system PerceptTM Medtronic®
Who cannot join
- Secondary cluster headache
- Patients implanted with another device of deep brain stimulation
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hopitaux de Marseille
Marseille
Anne BALOSSIER, MD
About this study
Official title: Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients Treated by Deep Brain Stimulation : a Feasibility Study
The physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (CH) is still partially unknown. Three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. There are many clinical arguments in favor of the involvement of the hypothalamus in CH. In addition, several radiological studies have confirmed the involvement of the posterior hypothalamic region in cluster attacks. Thus, a positron emission tomography study showed hyperactivity of the posteroinferior nucleus of the ipsilateral hypothalamus. Voxel based MRI studies have shown a bilateral increase in the volume of the inferoposterior part of the homolateral hypothalamus. The involvement of the posterior hypothalamic region or more precisely the ventral tegmental area of the midbrain therefore seems acquired, although its real role as a generator or modulator of pain remains to be precised.
Deep brain stimulation (dBS) is used in the management of chronic drug-resistant CH with an overall efficacy in 2/3 of patients. Nevertheless, its mechanism of action remains poorly understood, thus limiting the selection of patients and the optimization of care. The lack of clear neurophysiological criteria to identify the neuronal population to be targeted is a major source of uncertainty in the positioning of dBS electrodes and parameters adjustment. In order to improve the understanding and at the same time the results of this technique, obtaining in vivo electrophysiological data seems mandatory. Local fields potentials (LFP) have been recordered by in vivo by dBS in other diseases (Parkinson's disease, tremor…) and their analysis has brought new insigights in the characterization and understanding of these pathology. New generations of neurostimulator (Percept Medtronic) enables continuous recording of LFP in implanted patients. The goal of our study is the recording of LFP at the time of CH attacks via the BrainSenseTM system. This system included in the stimulator allows in vivo collection of LFP in the absence and presence of stimulation. The pathophysiological data recordered will then be correlated with the clinical benefit of the dBS ( nulber of attacks, duration, pain intensity…). As it is a feasibility study, only 5 patients will be included.
- Conditions
- Cluster Headache, Trigeminal Autonomic Cephalgia
- Being tested
- Local Field potential recording
- Keywords
- Hypothalamus, Local Fields Potentials
- Medical subject headings
- Cluster Headache, Trigeminal Autonomic Cephalalgias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Field potential recordingOther
Continuous recording of Local Field potentials in patients implanted with Deep brain stimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Local field potentials
Local field potentials amplitudes registered by the patient during a cluster attack
Measured: Between 0 to 12 months
Secondary outcomes (4)
Change in Efficacy of deep brain stimulation on attacks frequency
Frequency of cluster attacks
Measured: Between 0 to 12 months
Change in Efficacy of deep brain stimulation on pain intensity
Pain intensity of cluster attacks
Measured: Between 0 to 12 months
Change Efficacy of deep brain stimulation in attacks duration
Duration of cluster attacks
Measured: Between 0 to 12 months
Change in Efficacy of deep brain stimulation on treatment
Medical treatments for cluster headache
Measured: Between 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start31 May 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857098
- Sponsor's protocol ID
- RCAPHM23_0056
- Acronym
- DETECT
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients Treated by Deep Brain Stimulation : a Feasibility Study
- ClinicalTrials.gov ID
- NCT05857098
- Acronym / sponsor ID
- DETECT / RCAPHM23_0056
- Conditions
- Cluster Headache, Trigeminal Autonomic Cephalgia
- Keywords
- Hypothalamus, Local Fields Potentials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 31 May 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (CH) is still partially unknown. Three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. There are many clinical arguments in favor of the involvement of the hypothalamus in CH. In addition, several radiological studies have confirmed the involvement of the posterior hypothalamic region in cluster attacks. Thus, a positron emission tomography study showed hyperactivity of the posteroinferior nucleus of the ipsilateral hypothalamus. Voxel based MRI studies have shown a bilateral increase in the volume of the inferoposterior part of the homolateral hypothalamus. The involvement of the posterior hypothalamic region or more precisely the ventral tegmental area of the midbrain therefore seems acquired, although its real role as a generator or modulator of pain remains to be precised.
Deep brain stimulation (dBS) is used in the management of chronic drug-resistant CH with an overall efficacy in 2/3 of patients. Nevertheless, its mechanism of action remains poorly understood, thus limiting the selection of patients and the optimization of care. The lack of clear neurophysiological criteria to identify the neuronal population to be targeted is a major source of uncertainty in the positioning of dBS electrodes and parameters adjustment. In order to improve the understanding and at the same time the results of this technique, obtaining in vivo electrophysiological data seems mandatory. Local fields potentials (LFP) have been recordered by in vivo by dBS in other diseases (Parkinson's disease, tremor…) and their analysis has brought new insigights in the characterization and understanding of these pathology. New generations of neurostimulator (Percept Medtronic) enables continuous recording of LFP in implanted patients. The goal of our study is the recording of LFP at the time of CH attacks via the BrainSenseTM system. This system included in the stimulator allows in vivo collection of LFP in the absence and presence of stimulation. The pathophysiological data recordered will then be correlated with the clinical benefit of the dBS ( nulber of attacks, duration, pain intensity…). As it is a feasibility study, only 5 patients will be included.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from refractry chronic cluster headache
Key inclusion criteria (3 listed)
- Adult patients (age : 18-70 years-old) suffering from refractory chronic cluster headache
- Patients eligible for a deep brain stimulation in the ventral tegmental area of the mesencephalon
- Patients implanted with a deep brain stimulation system PerceptTM Medtronic®
Key exclusion criteria (2 listed)
- Secondary cluster headache
- Patients implanted with another device of deep brain stimulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local Field potential recordingContinuous recording of Local Field potentials in patients implanted with Deep brain stimulation | Other | – |
Primary outcome
Change in Local field potentials
Time frame: Between 0 to 12 months
Local field potentials amplitudes registered by the patient during a cluster attack
4 secondary outcomes
Change in Efficacy of deep brain stimulation on attacks frequency
Time frame: Between 0 to 12 months
Change in Efficacy of deep brain stimulation on pain intensity
Time frame: Between 0 to 12 months
Change Efficacy of deep brain stimulation in attacks duration
Time frame: Between 0 to 12 months
Change in Efficacy of deep brain stimulation on treatment
Time frame: Between 0 to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache and Trigeminal Autonomic Cephalgia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne BALOSSIER, MD (0491384277 ext. +33, anne.balossier@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Local field potentials (time frame: Between 0 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.